Federal Public Health Laws Supporting Data Use and Sharing

1 Federal Public Health laws Supporting data Use and Sharing The role of Health information technology (HIT) in impacting the efficiency and effectiveness of healthcare delivery is As HIT has progressed, the law has changed to allow HIT to serve traditional Public Health functions. This issue brief summarizes Federal laws Supporting the use and Sharing of Health data within the developing Public Health HIT landscape. Collecting patient data for providing direct healthcare services (commonly called primary use ) is the cornerstone of healthcare practice. In recent years, Sharing of electronic patient data for Public Health uses has been given increased Health departments and other entities rely on data Sharing for research and analysis to support disease prevention and Health promotion in the population (commonly called secondary use of data ).

2 3 Law lays the foundation for the recording, storage, and use of electronic Health information (EHI). For example, law plays a significant role in enabling Health departments to use HIT to improve systems that individual patient information to track population Health trends and interface with similar HIT systems used by healthcare providers and facilities. In addition, law supports the Sharing of EHI to facilitate 1 See Julia Adler-Milstein, & Ashish K. Jha, Sharing clinical data electronically: A critical challenge for fixing the Health care system, 307 J. AM. MED. ASS N 1695 (2012); David Blumenthal & Marilyn Tavenner, The Meaningful Use Regulation for electronic Health Records, 363 NEW ENG. J. MED. 6, 501 (2010); Taylor Burke, The Health information technology provisions in the American Recovery and Reinvestment Act of 2009: implications for Public Health policy and practice, 125 PUB.

3 Health REPORTS 141 (2010); Neil Calman, et al., Strengthening Public Health and primary care collaboration through electronic Health records, 102 AM. J. PUB. Health 13 (2012); Daniel J. Friedman, et al., electronic Health records and US Public Health : current realities and future promise, 103 AM. J. PUB. Health 1560 (2013); Tiina Maenpaa, et al., The utilization rate of the regional Health information exchange: how it impacts on Health care delivery outcomes, 18 J. PUB. Health MGMT. & PRACTICE 215 (2012). 2 David Blumenthal & Marilyn Tavenner, The Meaningful Use Regulation for electronic Health Records, 363 NEW ENG. J. MED. 6, 501 (2010); Sharona Hoffman & Andy Podgurski, Big Bad data : Law, Public Health , and Biomedical Databases, MED. & ETHICS Suppl. 56 (Spring 2013). 3 See, , Charles Safran, Meryl Bloomrosen, W.

4 Edward Hammond, et al., Toward a National Framework for the Secondary Use of Health data : An American Medical Informatics Association White Paper, 14 J. AM. MED. INFORMATICS ASS N 1 9 (2007). surveillance, emergency and outbreak response, and Health communication, among other essential Public Health functions. This issue brief summarizes Federal laws that have shaped state, tribal, local, and territorial Health departments use of HIT, including laws that promote healthcare providers HIT implementation and use; laws that address how EHI collected for primary uses can be shared with healthcare providers and others for primary and secondary purposes, including Public Health activities; and Privacy laws that govern the types of EHI that can be disclosed and the permitted uses of EHI.

5 Promoting electronic Health Records to Improve Population Health While Health information collected for patient care has been used for Public Health purposes for decades, the transition from paper to electronic records has revolutionized the efficiency, capacity, and functions of the US Health system. The electronic revolution in the healthcare sector spreads into the Public Health sector by improving the overall value of information and the ease of Sharing 4 Federal law has been a driving force in HIT s implementation and Enacted as part of the American Recovery and Reinvestment Act of 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act launched reforms to promote the use of HIT by private providers serving Medicare and Medicaid HITECH Act provisions Established the Office of the National Coordinator for Health Information Technology and committees that provide standards and specifications for HIT quality;7 Required Federal agencies to use HIT and provide for its voluntary use by private providers.

6 8 Provided for testing, research, grants, and loans for implementation and demonstrations for HIT education, including financial assistance to states and tribes;9 Applied privacy and security requirements and penalties to HIT and required audits and enforcement;10 and Secured incentive payments through the Centers for Medicare and Medicaid Services (CMS) for professionals and hospitals that are deemed eligible based on their meaningful use of certified electronic Health record (EHR) 4 Tara Ramanathan, et al., The Role of Law in Supporting Secondary Use of electronic Health Information, 43 MED. & ETHICS (forthcoming 2015). 5 Id. 6 42 ch. 156, available at 7 42 300jj-11. 8 Id. 17901. 9 Id. 17911, 17912, 300jj-31-300jj-38).

7 10 42 17921-17953. 11 Id. 300jj-31; 42 , ; EHR incentive programs, CENTERS FOR MEDICARE AND MEDICAID SERVICES, (last accessed Dec. 4, Regulations set three stages of requirements for professionals and facilities to adopt certified EHR3 12 technologies and use them for certain purposes, including Public Health The Stage 1 meaningful use regulations that became effective in 2012 set standards for data capture, use, and Sharing that providers must meet for The Stage 1 standards support EHR format uniformity and thus promote better care coordination and outreach to CMS guidelines clarify that meaningful use includes the goal of improving population Health outcomes, thus establishing link between HIT in the medical community and Public Health . In addition to the standards relating to patient care, Stage 1 meaningful use regulations include standards that can promote secondary uses of Health data to support Public Health activities.)

8 For example, providers can demonstrate meaningful use by generating reports of patients with a specific Health condition to foster quality improvement, identify and reduce disparities, support research, and facilitate Providers can demonstrate Stage 1 meaningful use by using EHR systems to submit data to immunization information systems pursuant to applicable Stage 1 also allows providers to demonstrate meaningful use by using EHR systems to communicate syndromic surveillance data to Public Health For providers who demonstrate Stage 1 standards,19 the Stage 2 regulations introduce new requirements for demonstrating meaningful use. As in Stage 1, Stage 2 requirements include standards that providers must adopt for incentive payments as well as a menu of standards to give providers some flexibility in demonstrating meaningful Many Stage 1 requirements are incorporated in the Stage 2 regulations to aid progression between meaningful use Stage 2 standards include 2013) (providing Medicaid payments of $63,750 over six years and Medicare payments of $44,000 over five years for professionals who adopt certified EHRs by 2016, but a 1 3% graduated penalty for only Medicare payments for those physicians who do not by 2015).

9 12 This issue brief uses the term electronic Health record or EHR to refer to patient record systems operated by healthcare providers. In contrast, the term electronic Health information or EHI to refers more broadly to digital Health information that may or may not be stored in EHR systems. 13 , Meaningful Use Criteria and How to Attain Meaningful Use of EHRs, (last accessed Mar. 4, 2015); Health , ONC, and CMS EHR Incentive Programs and Certification (last accessed Mar. 4, 2015); EHR Incentive Programs supra (laying out specific requirements for professionals under Medicare and Medicaid). 14 42 15 , supra. 16 42 (e)(3), (g)(4). 17 Id. (e)(9), (g)(9). 18 42 (e)(10), (g)(10). 19 See Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid electronic Health Record (EHR) Incentive Program for 2014, 79 Fed.

10 Reg. 171, 52910 (Sept. 4 2014) (providing a timetable illustrating the progression of meaningful use stages). 20 See 42 (j-m). 21 See , Stage 1 vs. Stage 2 Comparison Table for Eligible Professional (last accessed Dec. 29, 2014). requirements for clinical care and interoperability for EHRs, including Health Information Exchanges (HIE), electronic prescribing , transmission of records across settings, and increased patient 22 Like Stage 1, Stage 2 includes standards that promote Public Health activities, including laboratory reporting, reporting to immunization information systems, reporting to cancer registries and other specialized registries, submitting syndromic surveillance data , and identifying patients with specific Stage 3, projected to take effect in 2017, seeks to improve quality, safety, efficiency, and Health outcomes, emphasizing population Health Encouraging electronic data Use and Sharing with Stakeholders In addition to encouraging provider adoption of EHR s, HITECH s incentives encourage Sharing Health information with stakeholders.